Senior Device Development Engineer

BioSpace; Town of East Greenbush (NY); On-site; USD 75,000 - 144,000; Full time

Job summary

Regeneron in East Greenbush, NY is seeking a Senior Device Development Engineer to join the New Technologies, Combination Products Innovation team. You will lead front-end innovation projects and manage early-stage device design and development programs, translating patient and stakeholder needs into innovative device solutions.

You will work cross-functionally to define requirements, conduct feasibility studies, and partner with external teams to advance drug-delivery systems while upholding

Qualifications

• BS in Engineering field; Biomedical or Mechanical Engineering is preferred
• Device Development Engineer: 2+ years of experience
• Sr. Device Development Engineer: 5+ years of experience
• Experience with design history file management (21 CFR 820.30)
• Experience with delivery device branding/marketing is preferred

Responsibilities

• Lead and influence drug-device combination product scenario planning with cross-functional input.
• Research market trends and patient needs to identify innovation opportunities and advise device strategy.
• Perform feasibility evaluations and due diligence with external partners.
• Lead early-stage drug delivery system design with multi-functional teams.
• Generate insights from exploratory research to inform the portfolio.
• Maintain a culture of continuous improvement for safety and delivery.
• Represent Regeneron at industry meetings and forums.
• Demonstrate strong communication and strategic alignment.
• Possess project management skills to work across teams.

Skills

Cross-functional collaboration

Strong communication

Presentation skills

Strategic alignment

Education

BS in Engineering

Tools

21 CFR 820.30

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Device Development Engineer to join our New Technologies, Combination Products Innovation team. This engineer will be responsible for front-end innovation projects and scenario planning to support Regenerons growing pipeline, working cross-functionally to define patient, user, and business needs, identify and advocate for novel device solutions and opportunities, and manage early-stage device design and development programs.

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Device Development Engineer to join our New Technologies, Combination Products Innovation team. This engineer will be responsible for front-end innovation projects and scenario planning to support Regenerons growing pipeline, working cross-functionally to define patient, user, and business needs, identify and advocate for novel device solutions and opportunities, and manage early-stage device design and development programs.

When & Where

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm

Discover Your Role

• Lead and influence drug-device combination product scenario planning for new and lifecycle management programs, collaborating cross-functionally to gather stakeholder input, drive strategic decisions, and gain buy-in on long-term device strategies within therapeutic areas
• Research, monitor, and analyze drug delivery system industry and market trends, competitive landscapes, internal pipeline drug delivery needs, and patient/user needs to identify innovation opportunities and advise device strategy
• Perform technical feasibility evaluations and due diligence assessments, working with external strategic partners to drive toward innovative device solutions
• Lead early-stage drug delivery system design efforts with a multi-functional team, translating business needs and stakeholder requirements into comprehensive project plans and innovative product design
• Generate insights through exploratory, user, and foundational research to inform the drug delivery system portfolio, collaborating with technical teams, human factors, commercial, clinical, and other subject matter experts as applicable
• Maintain a culture of continuous improvement that strives to ensure safety and efficacy while accelerating delivery of commitments
• Represent Regeneron and the device teams at appropriate industry meetings and forums
• Demonstrate strong communication, presentation skills and can strategic alignment
• Possess project management skills and can work effectively across multiple functional teams

This Role Requires

• BS in Engineering field; Biomedical Engineering or Mechanical Engineering is preferred
  • Device Development Engineer: 2+ years of experience
  • Sr. Device Development Engineer: 5+ years of experience
  • Experience with design history file management (21 CFR 820.30)
  • Experience with delivery device branding/marketing is preferred
• Level is determined based on qualifications relevant to the role

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$75,300.00 - $143,900.00